Company name
Xaga Surgical AB

When was the company founded?
2016

Do you have any academic affiliations or collaborations?
Yes. Andreas Forsvall, founder of Xaga Surgical, is an MD and PhD, specialist in Surgery and Urology, researcher at Lund University, and practicing urologist.

The company also has an extensive network of physicians within infection prevention and urology in Sweden and the United States.

Describe your company
Xaga Surgical is redefining one of medicine’s oldest tools: the needle. The company’s patented platform addresses two major and costly challenges in needle-based procedures — bacterial transfer and poor targeting.

Its first application, the FDA-cleared Forsvall Biopsy Instrument, is designed to improve precision, reduce infection risk and integrate into existing clinical workflows for prostate biopsy procedures.

With broad platform potential across multiple high-volume procedures, Xaga Surgical is not developing a single product, but a new standard for safer and smarter needle-based care.

Describe your product/solution
The Forsvall Biopsy Instrument is a next-generation prostate biopsy system engineered for the MRI-first era. It combines a reusable biopsy gun with a patented single-use needle featuring a closed tip and smooth outer surface, unlike conventional open Tru-Cut designs.

Its On-Target Technology is designed to reduce needle deviation and significantly improve targeting accuracy, supporting improved cancer diagnostics. The system also addresses infection prevention and has demonstrated a 96% reduction in bacterial transfer.

The platform combines precision, safety and diagnostic performance in a single solution. The technology is scalable to multiple biopsy applications, while the infection-prevention technology has potential relevance for a broad range of medical needles. The company also holds a strong intellectual property portfolio.

What problem are you addressing?
Xaga Surgical addresses two major clinical challenges: suboptimal cancer diagnostics and procedure-related infections.

In prostate biopsy, the conventional Tru-Cut needle — still based on a 1969 design — can deviate within tissue and miss suspected cancer areas, impairing diagnostic accuracy.

At the same time, conventional needles may transport bacteria deep into tissue, contributing to infections that hospitalize approximately 2% of patients.

The Forsvall Biopsy Needle is designed to address both challenges in a single solution.

The platform is scalable across soft-tissue biopsies such as breast, liver and kidney, and also has broader potential to reduce needle-related infections in procedures including amniocentesis, orthopedic punctures, dialysis and chemotherapy access.

Overall, these challenges affect an estimated 50 million patients and contribute to approximately USD 80 billion annually in preventable infections and suboptimal cancer diagnostics.

What impact does your solution create?
The solution targets two major healthcare burdens: missed cancer diagnoses and procedure-related infections.

More than 4 million prostate biopsy procedures are performed annually, with approximately 2% resulting in infection-related hospitalization. Conventional biopsy methods also carry a significant risk of suboptimal sampling or missed and misclassified cancers.

Beyond prostate biopsy, the platform is applicable to breast, liver and kidney biopsies, representing a combined market of approximately 25 million biopsy procedures annually. The technology also has potential in high-volume needle procedures such as dialysis, amniocentesis and venous ports, representing more than 100 million punctures annually.

Dialysis access procedures carry an estimated annual infection risk of 7–14%, while venous ports have an infection rate of approximately 5% annually. Around 2 million venous ports are placed every year, with infection costs estimated at approximately USD 50,000 per case.

Overall, the company estimates that its technology addresses healthcare costs of approximately USD 80 billion globally while offering the potential to significantly reduce morbidity and mortality.

What stage of commercialisation are you currently in?
The Forsvall Biopsy Instrument received FDA 510(k) clearance in 2025. Sales activities and clinical trials are currently ongoing in the United States.

CE marking is expected in May 2026, with European sales planned to begin in June 2026 and additional studies starting in Q3 2026.

What are you currently seeking to take the next step?
Xaga Surgical is currently seeking funding to scale sales and production, including expansion into broader soft-tissue biopsy applications.

The company is also seeking funding to expand the platform into additional needle applications beyond biopsy, including venous ports and amniocentesis.

In parallel, Xaga Surgical is looking for partnerships related to sales, distribution and potentially manufacturing.

What market potential do you see for your solution?
Xaga Surgical’s vision is for its technology to replace conventional medical needles across biopsies and high-risk puncture procedures such as amniocentesis, venous ports and dialysis access.

The company aims to address approximately 1% of the 18 billion medical needles used globally each year.

The market strategy is to expand stepwise through clinical trials focused on infection prevention and cancer diagnostics, while working closely with key opinion leaders and supporting future inclusion in clinical guidelines.

 

Website:
https://xagasurgical.com/

Contact:
Andreas Forsvall
CEO
andreasforsvall@xagasurgical.com

Read more about the future of the medical needle